CN1733038A - Novel drug administering route of saussurea involucrate injection and its preparation process - Google Patents
Novel drug administering route of saussurea involucrate injection and its preparation process Download PDFInfo
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- CN1733038A CN1733038A CN 200510087732 CN200510087732A CN1733038A CN 1733038 A CN1733038 A CN 1733038A CN 200510087732 CN200510087732 CN 200510087732 CN 200510087732 A CN200510087732 A CN 200510087732A CN 1733038 A CN1733038 A CN 1733038A
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Abstract
The invention relates to the novel route for administration of Chinese medicinal injection for treating acute, chronic rheumatic arthritis, rheumatoid arthritis and joint ache caused by ostarthritis, the process for its preparation, and new indications. The injection is prepared from Tianshan snow saussurea as the raw material, and can be made into concentrated solution, freeze-dried powder injection, germ-free powder, 5% glucose injection, and 0.9% sodium chloride injection.
Description
Technical field:
The present invention relates to the agent of Chinese medicine preparation snow lotus injection new route of administration and preparation technology thereof.
Technical background:
Arthritis is one group of diseases associated with inflammation that involves the joint of general reference, the position that is the pathological changes infringement is the joint of human body, that the joint has is red, swollen, hot, bitterly, handicapped inflammation performance, or each tissue that constitutes the joint on the pathology have rotten, ooze out, hypertrophy sexually revises and is arthritis.In China, 100,000,000 above arthritics are arranged.Doctors confirm that the arthritic is just increasing with surprising numeral, and arthritic ill situation worsens rapidly.What problem was more serious is, those people that are about to become the arthritic do not know how to prevent, and many arthritics also know nothing Therapeutic Method, some people even do not know it oneself is the arthritic.
At present, the Chinese medicine and western medicine of treatment of arthritis is a lot, but western medicine arthritis effect is undesirable, and Chinese medicine has special advantages aspect treatment of arthritis, utilize anti-inflammatory analgesic, detumescence method treatment of arthritis that certain effect is arranged.
Herba Saussureae Involueratae belongs to herbaceos perennial for the Compositae Radix Aristolochiae, and the Herba Saussureae Involueratae injection that is extracted by the Herba Saussureae Involueratae herb has anti-inflammatory analgesic, blood circulation promoting and blood stasis dispelling function, clinical rheumatic arthritis, rheumatoid arthritis, the osteoarthritis etc. of being used for the treatment of.
The effective ingredient of Herba Saussureae Involueratae injection is a total flavones.Modern pharmacology confirms that antiinflammatory action is the general character of flavone compound, and its mechanism of action is to suppress phospholipase A
2Activity, thereby reduced the generation of prostaglandin and leukotriene.
The total flavones that kinds of experiments demonstrates in the Herba Saussureae Involueratae injection can significantly increase the synthetic of chondrocyte proteoglycan, protein and DNA, thereby brings into play its antiinflammatory, detumescence, analgesia, curing rheumatism, dredge the meridian passage, human body immunity improving power, effects such as blood circulation promoting and blood stasis dispelling.
But, Herba Saussureae Involueratae injection adopts the intramuscular injection method aspect clinical practice, absorb by tissue, speed is slower, and dosage is less, effect to diseased region is less, and both increased patient's misery, also can cause the injection site scleroma, even swell and ache, secondary infection, often having an injection also causes " hip contracture " easily.This administrated method significantly limits its clinical practice.Therefore, at this problem, we have developed the intravenously administrable approach, have overcome to absorb shortcoming slow, that onset time is long.Both increased clinical effective dose, and can comparatively fast absorb again, blood drug level is higher, has improved bioavailability, and more convenient for clinical practice, more preferably the patient serves.
Summary of the invention:
The invention provides the agent of folk prescription snow lotus injection, be raw material and add the suitable medicinal ejection preparation that suitable adjuvant is prepared from by Herba Saussureae Involueratae.
Preparation type involved in the present invention, comprise small-volume injection (injection, concentrated solution for injection), bulk capacity injection (5% glucose injection, 0.9% sodium chloride injection) and specific type injection dosage forms such as (lyophilized powder, sterilized powders), wherein:
(1) preparation process of injection is as follows: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, it is an amount of that filtrate adds F-68, stirs, and with 40% sodium hydroxide solution regulated value to 6.0～8.0, filters with microporous filter membrane (0.2 μ m), and filtrate adds the nearly full dose of injection water, embedding, and sterilization, promptly.
(2) preparation process of freeze-dried powder is as follows: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds an amount of and mannitol of F-68 and stirs, with 40% sodium hydroxide solution regulated value to 6.0～8.0, filter with microporous filter membrane (0.2 μ m), filtrate adds injection water nearly full dose, the filtrate fill in the cillin bottle of 15ml, every bottled 2～7ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.After the lyophilization 24 hours, tamponade, roll lid, make dried frozen aquatic products, promptly;
(3) preparation process of sterilized powder is as follows: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Getting this solution filters, filtrate adds F-68 and mannitol is an amount of, stir, with 40% sodium hydroxide solution regulated value to 6.0～8.0, after an amount of dissolving of adding mannitol, filter with microporous filter membrane (0.2 μ m), filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly.
(4) preparation of concentrated solution for injection: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and mannitol is an amount of, stirs, with 40% sodium hydroxide solution regulated value to 6.0～8.0, filter with microporous filter membrane (0.2 μ m), and embedding, sterilization, promptly.
The preparation of (5) 5% glucose injections: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 10g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and glucose is an amount of, stirs, with 40% sodium hydroxide solution regulated value to 6.0～8.0, filter with microporous filter membrane (0.2 μ m), and embedding, sterilization, promptly.
The preparation of (6) 0.9% sodium chloride injections: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 10g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and sodium chloride is an amount of, stirs, and with 40% sodium hydroxide solution regulated value to 6.0～8.0, filters with microporous filter membrane (0.2 μ m), and filtrate is evaporated under aseptic condition in right amount, embedding, and sterilization, promptly.
During more than prescription was formed, the weight of raw material of Chinese medicine medicine was calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as 1000 of injection, freeze-dried powder is 1000 bottles, each consumption is 1～3 (or bottle).
Folk prescription snow lotus injection of the present invention agent, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Folk prescription snow lotus injection preparation of the present invention as injection, can be drawn 1～3 with disposable syringe in use, adopts intramuscular injection, and after also pharmaceutical liquid can being diluted with 0.9% normal saline, 10～40ml, intravenous injection was slowly injected in 5～8 minutes; Also can be diluted in 0.9% sodium chloride injection or 5% glucose injection, 250～500ml, vein splashes into.For lyophilized injectable powder, can adopt the said method administration with after the sterilized water for injection dissolving.
Following data declaration beneficial effect of the present invention by experiment:
For the whether equivalence of the curative effect that proves new route of administration and original route of administration, or be any more effective, we have compared the curative effect difference of intravenously administrable and two kinds of administering modes of intramuscular administration with regard to the clinical efficacy of Herba Saussureae Involueratae injection, done preclinical zoopery, concrete grammar and result are as follows:
One, to the influence of antiinflammatory and analgesic activity
1, animal and material
NIH mice and SD rat; Herba Saussureae Involueratae injection (Western Regions, Xinjiang pharmaceutical factory); Carrageenin; 1640 culture medium; Concanavalin A, Con A; Lipoprotein etc.
2, method and result
2.1 bringing out the influence of rat foot claw swelling, on Carrageenan chooses 40 of healthy rats, body weight 186 ± 35g, be for 5 monthly ages, the male and female dual-purpose, be divided into two groups of intravenously administrable experimental group and intramuscular administration matched groups according to the body weight equilibrium, each organizes the volume (mmHg post) of all measuring right back pawl before the rat administration with sufficient pawl analyzer.Continuous use is 3 days then, causes the swelling degree that rat foot claw is surveyed in scorching back with carrageenin after the last administration.The result shows two groups of swelling degree that all can obviously suppress rat foot claw of Herba Saussureae Involueratae injection, but intravenously administrable group curative effect obviously is better than the intramuscular administration group, and the experimental group suppression ratio is 25～59%, and matched group is 18～42%; The acting duration of experimental group is more than 6 hours, and matched group is 4 hours, and intensity obviously is better than matched group.
2.2 analgesic activity
50 of healthy female mices, body weight 25 ± 1.6g eases pain incubation period within 30s.Be divided into negative control group (NS) according to the body weight equilibrium, intramuscular injection Herba Saussureae Involueratae injection positive controls (10ml/kg), intravenous injection Herba Saussureae Involueratae injection experimental group (10ml/kg).Once a day, logotype is 7 days.1h after the last administration measures and record mice pain incubation period the result with hot plate method, two groups of Herba Saussureae Involueratae injections all can make prolongation of latency with respect to negative control group, but with the intravenously administrable group serves as strong, and effect continued more than 5 hours, and the two relatively has notable difference (P＜0.05).
2.3 analgesia and repair to central nervous system injury
Get 30 of healthy adult dogs, body weight 11～15kg is divided into two groups at random, and promptly experimental group is 15,15 of matched groups.Two groups all add local anaesthesia in ketamine 10mg/kg intramuscular injection and finish epidural puncture and put pipe, disappear to local anaesthesia, animal is clear-headed fully, push 1.5% lignocaine 5ml through conduit, when all hemorrhage two backs acroparalysis is unable, confirm that conduit is in chamber, the dura mater outside, with Herba Saussureae Involueratae injection intravenous injection 5ml/ time, once a day, continuous 7 days, take out behind the conduit and observed 2 months.Found that the continuous observation of experimental group and matched group is after 2 months, 15 dogs of experimental group are with respect to matched group, the extremity autonomic activities is normal, painful, sense of touch and warm-cold sensitivity exist, growth promoter is good, do not find the bad performance of neuromuscular, curative effect obviously is better than matched group, and the two relatively has notable difference.
Therefore, above all experiments show that Herba Saussureae Involueratae injection changes route of administration can obviously increase its curative effect, is better than original route of administration, is worth at clinical expansion.
Two, toxicologic study
Acute toxicity test shows that the mouse tail vein injection Herba Saussureae Involueratae injection is not measured LD
50
Long term toxicity test: mice group, every day tail vein injection once, connect and annotate 90d, the result, administration group mice and control group mice movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, Herba Saussureae Involueratae injection is a kind of antibiosis anti-inflammatory drug preferably, to various urgency, chronic rheumatic arthritis, scapulohumeral periarthritis, rheumatoid arthritis and bone joint pain, sciatica, arthritis, radiculitis, Radial styloid tenosynovitis, sacroiliitis, disease treatment such as knee-joint pain and sciatica has the important clinical meaning, and changing original intramuscular administration is intravenously administrable, can obviously increase its antiinflammatory, detumescence, the analgesic clinical efficacy that waits, there is not tangible toxicity in addition, prolonged application safety, therefore, being worth clinical further applies.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of injection of the present invention:
Prescription: Herba Saussureae Involueratae 500g
F-68 4g
Water for injection adds to 1000ml
Preparation method:
Get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 4g, stirs, and regulates pH value to 6.0～8.0 with 40% sodium hydroxide solution, filters with microporous filter membrane (0.2 μ m), and filtrate adds the nearly 1000ml of injection water, embedding, and sterilization, promptly.
Embodiment 2
The preparation process of freeze-dried powder of the present invention is as follows:
Prescription: Herba Saussureae Involueratae 2500g
F-68 20g mannitol 50g
Water for injection adds to 1000ml
Preparation method:
Get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and mannitol, stirs, regulate pH value to 6.0～8.0 with 40% sodium hydroxide solution, filter with microporous filter membrane (0.2 μ m), filtrate adds the nearly full dose of injection water, the filtrate fill in the cillin bottle of 15ml, every bottled 2～7ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.After the lyophilization 24 hours, tamponade, roll lid; Make dried frozen aquatic products, promptly get 500 bottles.
Embodiment 3
The preparation process of sterilized powder of the present invention is as follows:
Prescription: Herba Saussureae Involueratae 2500g
F-68 20g mannitol 200g
Water for injection adds to 1000ml
Preparation method:
Get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and mannitol, stirs, and regulates pH value to 6.0～8.0 with 40% sodium hydroxide solution, filter with microporous filter membrane (0.2 μ m), filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly.
Embodiment 4
The preparation of concentrated solution for injection of the present invention:
Prescription: Herba Saussureae Involueratae 2500g
F-68 20g
Water for injection adds to 1000ml
Preparation method:
Get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68, stirs, and regulates pH value to 6.0～8.0 with 40% sodium hydroxide solution, filter with microporous filter membrane (0.2 μ m), and sterilization, promptly.
Embodiment 5
The preparation of the present invention's 5% glucose injection:
Prescription: Herba Saussureae Involueratae 500g
F-68?4g
Glucose 50g
Water for injection adds to 1000ml
Preparation method:
Get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and glucose is an amount of, stirs, and regulates pH value to 6.0～8.0 with 40% sodium hydroxide solution, filter with microporous filter membrane (0.2 μ m), and embedding, sterilization, promptly.
Embodiment 6
The preparation of the present invention's 0.9% sodium chloride injection:
Prescription: Herba Saussureae Involueratae 500g
F-68 4g
Glucose 9g
Water for injection adds to 1000ml
Preparation method:
Get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 0.3g and sodium chloride 9g, stirs, and regulates pH value to 6.0～8.0 with 40% sodium hydroxide solution, filter with microporous filter membrane (0.2 μ m), and embedding, sterilization, promptly.
Claims (5)
1. a folk prescription injection that is used for diseases such as various acute and chronic rheumatic arthritis, scapulohumeral periarthritis, rheumatoid arthritis and bone joint pain is characterized in that with the Herba Saussureae Involueratae being that raw material and adjuvant are made.
2. the new route of administration of claim 1 refers to that Herba Saussureae Involueratae injection is used for multiple intravenously administrables such as intravenous drip, intravenous injection.
3. the ejection preparation of claim 1 is characterized in that small-volume injection (injection, concentrated solution for injection), bulk capacity injection (5% glucose injection, 0.9% sodium chloride injection) and specific type injection dosage forms such as (lyophilized powder, sterilized powders).
4. the injection of claim 3 is characterized in that, contains excipient in the preparation, and excipient is selected from: mannitol, sorbitol, lactose.
5. the preparation method of any one injection of claim 1-4 is characterized in that:
(1) preparation process of injection is as follows: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 1g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, it is an amount of that filtrate adds F-68, stirs, and with 40% sodium hydroxide solution regulated value to 6.0～8.0, filters with microporous filter membrane (0.2 μ m), and filtrate adds the nearly full dose of injection water, embedding, and sterilization, promptly.
(2) preparation process of freeze-dried powder is as follows: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, it is an amount of that filtrate adds F-68, stirs, and with 40% sodium hydroxide solution regulated value to 6.0～8.0, filters with microporous filter membrane (0.2 μ m), and filtrate adds the nearly full dose of injection water, the filtrate fill in the cillin bottle of 20ml, every bottled 5～7ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.After the lyophilization 24 hours, tamponade, roll lid, make dried frozen aquatic products, promptly;
(3) preparation process of sterilized powder is as follows: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Getting this solution filters, it is an amount of that filtrate adds F-68, stir, with 40% sodium hydroxide solution regulated value to 6.0～8.0, after an amount of dissolving of adding mannitol, filter with microporous filter membrane (0.2 μ m), filtrate is sprayed with the spray drying tower under the aseptic condition, makes the aseptic powder art, packing, labeling, promptly.
(4) preparation of concentrated solution for injection: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 5g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and mannitol is an amount of, stirs, with 40% sodium hydroxide solution regulated value to 6.0～8.0, filter with microporous filter membrane (0.2 μ m), and embedding, sterilization, promptly.
The preparation of (5) 5% glucose injections: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 10ml and contains crude drug 1g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and glucose is an amount of, stirs, with 40% sodium hydroxide solution regulated value to 6.0～8.0, filter with microporous filter membrane (0.2 μ m), and embedding, sterilization, promptly.
The preparation of (6) 0.9% sodium chloride injections: get Herba Saussureae Involueratae, add 85% alcohol dipping 14 days, filter, filtrate is concentrated into every 1ml and contains crude drug 10g, puts in the container in 110 ℃, 0.1kP sterilization 45 minutes, places 1～3 month.Get this solution and filter, filtrate adds F-68 and sodium chloride is an amount of, stirs, and with 40% sodium hydroxide solution regulated value to 6.0～8.0, filters with microporous filter membrane (0.2 μ m), and filtrate is evaporated under aseptic condition in right amount, embedding, and sterilization, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510087732 CN1733038A (en) | 2005-08-08 | 2005-08-08 | Novel drug administering route of saussurea involucrate injection and its preparation process |
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|---|---|---|---|
| CN 200510087732 CN1733038A (en) | 2005-08-08 | 2005-08-08 | Novel drug administering route of saussurea involucrate injection and its preparation process |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101209274B (en) * | 2007-12-25 | 2011-05-11 | 新疆维吾尔自治区药物研究所 | Saussurea involucrata extract and and producing method thereof |
| CN104435043A (en) * | 2014-12-05 | 2015-03-25 | 新疆银朵兰维药股份有限公司 | Medicine for treating arthritis-induced arthralgia and preparation method thereof |
-
2005
- 2005-08-08 CN CN 200510087732 patent/CN1733038A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101209274B (en) * | 2007-12-25 | 2011-05-11 | 新疆维吾尔自治区药物研究所 | Saussurea involucrata extract and and producing method thereof |
| CN104435043A (en) * | 2014-12-05 | 2015-03-25 | 新疆银朵兰维药股份有限公司 | Medicine for treating arthritis-induced arthralgia and preparation method thereof |
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